Ethics approval

Study design

Primary study design

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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Condition

Sedation/colonoscopy

Intervention

Patients in both groups initially received intravenously (IV) 2 mg (less than 70 kg body weight [b.w.]) or 3 mg (greater than 70 kg b.w.) of midazolam and 25 mg of pethidine. Additional midazolam was carefully titrated in boluses of 1 mg IV to achieve the desired level of sedation, moderate or deep according to the randomisation. Bolus doses of 25 mg pethidine were also given if patients complained of pain or if there were other indications of pain such as facial grimaces, movement and a sudden increase in heart rate.

Patients were treated with sedatives during the procedure (colonoscopy), which lasted from 15 to 45 min approximately for every patient. There wasn't follow up for any arm of our trial.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measure

Polyp detection rate, measured at end of study

Secondary outcome measures

Measured at end of study:1. Patients' and the endoscopists satisfaction2. Recovery time3. Adverse events related to sedation

Overall trial start date

06/06/2009

Overall trial end date

15/10/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients aged 50 years and older, either sex2. Undergoing colonoscopy for colorectal cancer (CRC) screening, postpolypectomy surveillance, or other indications for which the primary goal of the examination was detection of neoplasia